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Monkeypox vaccine wins EU approval

The approval is valid in all EU Member States, as well as in Iceland, Liechtenstein, and Norway

Published: Mon 25 Jul 2022, 12:14 PM

Updated: Mon 25 Jul 2022, 12:51 PM

  • By
  • Reuters

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On Monday, Danish biotechnology company Bavarian Nordic said that the European Commission had given permission for its Imvanex vaccine to be marketed as protection against monkeypox, as recommended last week by the European Medicines Agency (EMA).

The approval comes just a day after the World Health Organization issued a high-level alert, declaring the rapidly-spreading monkeypox outbreak as a global health emergency.

"The availability of an approved vaccine can significantly improve nations' readiness to fight emerging diseases, but only through investments and structured planning of the biological preparedness," said Bavarian Chief Executive Paul Chaplin.

Bavarian's vaccine, the only one to have won approval for the prevention of monkeypox disease in the United States and Canada, has, in the EU, so far only been approved to treat smallpox. Yet, the company has supplied the vaccine to several EU countries during the current monkeypox outbreak, for what is known as "off-label" use.

The approval is valid in all European Union Member States, as well as in Iceland, Liechtenstein, and Norway, explained Bavarian Nordic, in a statement.

They also added that the development of Imvanex was made possible through significant investments from the US government during the past two decades.



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